INDICATIONS AND USAGE

TEMODAR is an alkylating drug indicated for the treatment of adult patients with:

• Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment. (1.1)
• Refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. (1.2)

DOSAGE AND ADMINISTRATION

• Newly Diagnosed GBM: 75 mg/m2 for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m2 once daily for Days 1–5 of a 28-day cycle of TEMODAR for 6 cycles. (2.1)
• Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. (2.1)
• The recommended dose for TEMODAR as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when TEMODAR for Injection was given over 90 minutes. (2.1, 12.3)

DOSAGE FORMS AND STRENGTHS

• 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg capsules. (3)
• 100-mg powder for injection. (3)

CONTRAINDICATIONS

• Known hypersensitivity to any TEMODAR component or to dacarbazine (DTIC). (4.1)

WARNINGS AND PRECAUTIONS

• Myelosuppression - monitor Absolute Neutrophil Count (ANC) and platelet count prior to dosing and throughout treatment. Geriatric patients and women have a higher risk of developing myelosuppression. (5.1)
• Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed. (5.2)
• Pneumocystis carinii pneumonia (PCP) – prophylaxis required for all patients receiving concomitant TEMODAR and radiotherapy for the 42-day regimen for the treatment of newly diagnosed glioblastoma multiforme. (5.3)
• All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP. (5.4)
• Complete blood counts should be obtained throughout the treatment course as specified. (5.4)
• Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving TEMODAR. (5.5)
• As bioequivalence has been established only when given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing; the possibility of an increase in infusion related adverse reactions cannot be ruled out. (5.6)

ADVERSE REACTIONS

• The most common adverse reactions (≥10% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, coordination abnormal, viral infection, amnesia, and insomnia. (6.1)
• The most common Grade 3 to 4 hematologic laboratory abnormalities (≥10% incidence) that have developed during treatment with temozolomide are: lymphopenia, thrombocytopenia, neutropenia, and leukopenia. (6.1)
• Allergic reactions have also been reported. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Schering Corporation, a subsidiary of Merck & Co., Inc. at 1-800-526-4099 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

• Valproic acid: decreases oral clearance of temozolomide. (7.1)

USE IN SPECIFIC POPULATIONS

• Nursing mothers: Not recommended. (8.3)
• Pediatric use: No established use. (8.4)
• Hepatic/Renal Imp

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